FDA.reportPublic FDA data

Application 216228

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALIPERIDONE PALMITATEPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INJECTABLE273MG/0.88MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Erzofri extended-releasePALIPERIDONE PALMITATEShandong Luye Pharmaceutical Co., Ltd.492bf9dd-868e-421a-92db-8cca8973aac12026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE PALMITATE
INVEGA HAFYERAPALIPERIDONE PALMITATEJanssen Pharmaceuticals, Inc6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b2025-02-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE PALMITATE
INVEGA SUSTENNAPALIPERIDONE PALMITATEJanssen Pharmaceuticals, Inc.1af14e42-951d-414d-8564-5d5fce1385542025-02-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE PALMITATE
INVEGA TRINZAPALIPERIDONE PALMITATEJanssen Pharmaceuticals, Incc39e65d7-fa44-4e4c-8b12-a654d3ed0eae2025-02-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE PALMITATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78838ORIG 2024-06-20